FDA.reportPublic FDA data

Nifedipine

Product NDC
70771-1191
11-digit product format
707711191
Labeler code
70771
Product ID
70771-1191_b8c99bfa-b2c5-4436-8e84-54348a032311
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA210012
Marketing category
ANDA
Marketing start
2018-02-02
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812011, 1812013, 1812015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1191-0Nifedipine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005
70771-1191-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
70771-1191-3Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1191NIFEDIPINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 3 package rows20241212_ac3f68b2-29b5-45c1-b6a2-54704dc3143e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYac3f68b2-29b5-45c1-b6a2-54704dc3143e5
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYac3f68b2-29b5-45c1-b6a2-54704dc3143e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1191-0707711191001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1191-0) 2018-02-020000-00-00NoNoCurrent
70771-1191-170771119101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1191-1) 2018-02-020000-00-00NoNoCurrent
70771-1191-370771119103300 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1191-3) 2018-02-020000-00-00NoNoCurrent